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Trial record 15 of 75 for:    "Epidermolysis Bullosa"

Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)

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ClinicalTrials.gov Identifier: NCT01294241
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Amryt Pharma ( Birken AG )

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Inherited Epidermolysis Bullosa
Interventions: Drug: Oleogel-S10
Device: Mepilex® soft silicone faced polyurethane foam dressing

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 03 Nov 2010 to 14 Jun 2011 at 1 center (University Medical Center Freiburg) in 1 country (Germany).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
12 wounds in 10 participants (2 cycles of treatment in 2 participants) were treated with study medication. The reepithelialization was compared intra-individually in either 2 halves of an Epidermolysis bullosa (EB) wound ≥10 cm2 and ≤200 cm2 in size or in 2 EB wounds ≥5 cm2 in size, i.e. the total number of participants was 10 in the overall study.

Units Details
Units for given values
Values given as pairs: 1) number of participants and 2) number of units (Wounds)

Reporting Groups
  Description
All Study Participants One (half of an) EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with Oleogel-S10 and non-adhesive wound dressing. The other wound (half) was covered with a non-adhesive wound dressing only (Mepilex®) as control (intra-individual comparison).

Participant Flow:   Overall Study
    All Study Participants
Participants Units (Wounds)
STARTED   10   12 
COMPLETED   10   12 
NOT COMPLETED   0    



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As 2 participants received 2 cycles of treatment each, 12 wounds were treated with study medication.

Reporting Groups
  Description
All Study Participants One (half of an) EB wound ≥10 cm2 and ≤200 cm2 in size or 1 EB wound ≥5 cm2 in size was treated with Oleogel-S10 and non-adhesive wound dressing. The other wound (half) was covered with a non-adhesive wound dressing only (Mepilex®) as control.

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 10 
Overall Units Analyzed (Wounds) 
[Units: Wounds]
 12 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      5  50.0% 
Between 18 and 65 years      5  50.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Median (Full Range)
 20 
 (6 to 48) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3  30.0% 
Male      7  70.0% 
Region of Enrollment 
[Units: Participants]
 
Germany   10 


  Outcome Measures

1.  Primary:   Intra-individual Difference in Reepithelialization of Wound (Halves) at Day 14 in ‘Recent Wounds’ or Day 28 in ‘Chronic Wounds’   [ Time Frame: 14 days for 'recent wounds', 28 days for 'chronic wounds' ]

2.  Secondary:   Percentage of Wound Epithelialization at Day 7±1   [ Time Frame: Day 7±1 ]

3.  Secondary:   Percentage of Wound Epithelialization at Day 14±1   [ Time Frame: Day 14±1 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size, subjects with dystrophic Epidermolysis bullosa only, difficult wound size analysis at fixed study days due to several episodes of re-trauma in both intervention and control wounds


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Head of Clinical Development
Organization: Amryt Pharma
phone: +353 1 669 4606
e-mail: medinfo@amrytpharma.com



Responsible Party: Amryt Pharma ( Birken AG )
ClinicalTrials.gov Identifier: NCT01294241     History of Changes
Other Study ID Numbers: BEB-10
First Submitted: October 27, 2010
First Posted: February 11, 2011
Results First Submitted: October 22, 2016
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018